Demo

Senior Regulatory Affairs Specialist

PulmonX Corporation
Redwood, CA Full Time
POSTED ON 3/7/2025
AVAILABLE BEFORE 4/6/2025

Company Overview

Pulmonx is a Global Leader in Interventional Pulmonology, Planning Tools, and Treatments for Obstructive Lung Disease. Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is the maker of the Zephyr® Valve. The Zephyr Valve was granted breakthrough status and approved by the FDA in June 2018, because according to the FDA it “represents a breakthrough technology as the device offers bronchoscopic lung volume reduction without surgery and its associated risks. This device offers a significant, clinically meaningful advantage over the current standard of care and therefore, its availability is also in the best interest of patients.”

Position Overview

The Senior Regulatory Affairs Specialist will play a critical role in ensuring that the company’s medical devices comply with global regulations, focusing on managing submissions, audits, and postmarket obligations. This position requires strong regulatory knowledge, an ability to manage technical documentation, and expertise in regulatory compliance. The Senior Regulatory Affairs Specialist will collaborate across teams to manage complaint reporting, support audits, and ensure compliance with EU MDR and other applicable regulatory standards.

Responsibilities and Capabilities:

  • Oversee the regulatory aspects of complaint handling, ensuring compliance with internal processes and external regulatory requirements.
  • Assess and determine the reportability of complaints and adverse events to regulatory authorities, ensuring timely submission.
  • Provide regulatory support during internal and external audits, working closely with notified bodies and ensuring all documentation is in order.
  • Conduct assessments for product changes, clinical data, and documentation to confirm compliance with relevant regulations.
  • Ensure compliance with EU MDR by preparing and maintaining up-to-date technical documentation.
  • Manage the creation, maintenance, and updates of technical files to ensure product compliance with regulatory bodies.
  • Liaise with the (BSI, FDA and other agencies) and other notified bodies for certifications, registrations and ensuring alignment with regulatory standards.
  • Handle the process of acquiring and maintaining regulatory certifications, ensuring submissions are made in a timely manner for renewals and new product approvals.
  • Oversee regulatory-related fees and manage contracts with vendors related to submissions and certifications.

Requirements:

  • Bachelor’s degree in science, Engineering, or a related field. Understanding of ISO13485, ISO14971, FDA Complaint Management and reportability requirements, EU Vigilance reporting
  • Experience managing technical files, registrations and certifications
  • Minimum of 5 years of regulatory affairs, quality assurance experience in the medical device industry.
  • Strong project management skills and experience with technical documentation.
  • Knowledge of EU MDR, FDA, and other global regulatory requirements.
  • Excellent communication, leadership, and organizational skills.
  • Proficient in MS Word, PowerPoint, Excel, and regulatory submission tools

Compensation: $105,000 - $145,000 depending on experience

When joining Pulmonx, you are part of an organization that attracts and hires the best talent on the planet! You will be working with a great team of dedicated, friendly and collaborative individuals, developing novel and game changing product(s). We are dedicated to the development and growth of our colleagues.

Please note that an application and resume must be completed and submitted for consideration for this opportunity.

Pulmonx Corporation is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.

#LI-post

Salary : $105,000 - $145,000

If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

What is the career path for a Senior Regulatory Affairs Specialist?

Sign up to receive alerts about other jobs on the Senior Regulatory Affairs Specialist career path by checking the boxes next to the positions that interest you.
Income Estimation: 
$97,803 - $128,184
Income Estimation: 
$122,529 - $166,597
Income Estimation: 
$123,229 - $164,502
Income Estimation: 
$123,155 - $167,827
Income Estimation: 
$188,947 - $264,846
Income Estimation: 
$242,066 - $328,520
Income Estimation: 
$212,419 - $307,933
Income Estimation: 
$190,069 - $273,730
Income Estimation: 
$77,272 - $101,684
Income Estimation: 
$95,800 - $126,196
Income Estimation: 
$97,803 - $128,184
Income Estimation: 
$95,508 - $129,349
Income Estimation: 
$95,800 - $126,196
Income Estimation: 
$122,529 - $166,597
Income Estimation: 
$123,229 - $164,502
Income Estimation: 
$123,155 - $167,827
Income Estimation: 
$122,529 - $166,597
Income Estimation: 
$185,828 - $247,157
Income Estimation: 
$140,918 - $196,956
Income Estimation: 
$166,245 - $219,788

Sign up to receive alerts about other jobs with skills like those required for the Senior Regulatory Affairs Specialist.

Click the checkbox next to the jobs that you are interested in.

  • Compliance Management Skill

    • Income Estimation: $94,513 - $153,877
    • Income Estimation: $101,333 - $137,845
  • Filing Skill

    • Income Estimation: $123,229 - $164,502
    • Income Estimation: $308,977 - $498,049
View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

Job openings at PulmonX Corporation

PulmonX Corporation
Hired Organization Address Redwood, CA Full Time
Responsibilities and Capabilities: Strategic Communication Development Design and implement HCP-focused communication st...
PulmonX Corporation
Hired Organization Address Redwood, CA Full Time
Director / Sr. Director Regulatory Affairs Pulmonx is looking for an experienced Director / Sr. Director of Regulatory A...
PulmonX Corporation
Hired Organization Address San Francisco, CA Full Time
Director / Sr. Director Regulatory Affairs Pulmonx is looking for an experienced Director / Sr. Director of Regulatory A...
PulmonX Corporation
Hired Organization Address Clearwater, FL Full Time
We are currently seeking a Territory Account Manager to join our Sales team supporting our Southeast Region . This is an...

Not the job you're looking for? Here are some other Senior Regulatory Affairs Specialist jobs in the Redwood, CA area that may be a better fit.

Senior Regulatory Affairs Specialist

Ipro Networks Pte. Ltd., Sunnyvale, CA

Senior Regulatory Affairs Specialist (Hybrid)

Stryker Group, San Jose, CA

AI Assistant is available now!

Feel free to start your new journey!